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TURKISH STANDARD

TS EN 10993-1/AC:2010
Mart 2011

ICS 11.100.20

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Biological evaluation of medical devices - Part 1:

Evaluation and testing within a risk management
process - Technical Corrigendum 1 (ISO 109931:2009/Cor 1:2010)

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EN ISO 10993-1:2009/AC

EUROPEAN STANDARD
NORME EUROPENNE

June 2010
Juin 2010
Juni 2010

EUROPISCHE NORM
ICS 11.100.20

English version
Version Franaise
Deutsche Fassung

Biological evaluation of medical devices - Part 1: Evaluation and testing

within a risk management process - Technical Corrigendum 1 (ISO 109931:2009/Cor 1:2010)
valuation biologique des dispositifs
mdicaux - Partie 1: valuation et essais
au sein d'un processus de gestion du
risque - Rectificatif technique 1 (ISO 109931:2009/Cor 1:2010)

Biologische Beurteilung von

Medizinprodukten - Teil 1: Beurteilung und
Prfung im Rahmen eines
Risikomanagementverfahrens (ISO 109931:2009/Cor 1:2010)

This corrigendum becomes effective on 15 June 2010 for incorporation in the three official language
versions of the EN.
Ce corrigendum prendra effet le 15 juin 2010 pour incorporation dans les trois versions linguistiques
officielles de la EN.
Die Berichtigung tritt am 15.Juni 2010 zur Einarbeitung in die drei offiziellen Sprachfassungen der EN
in Kraft.

EUROPEAN COMMITTEE FOR STANDARDIZATION

COMIT EUROPEN DE NORMALISATION
EUROPISCHES KOMITEE FR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels

2010 CEN

All rights of exploitation in any form and by any means reserved worldwide for CEN national Members.
Tous droits d'exploitation sous quelque forme et de quelque manire que ce soit rservs dans le monde entier aux
membres nationaux du CEN.
Alle Rechte der Verwertung, gleich in welcher Form und in welchem Verfahren, sind weltweit den nationalen Mitgliedern
von CEN vorbehalten.
Ref. No.:EN ISO 10993-1:2009/AC:2010 D/E/F

EN ISO 10993-1:2009/AC:2010 (E)

Contents

Page

Foreword ..............................................................................................................................................................3

EN ISO 10993-1:2009/AC:2010 (E)

Foreword
This document (EN ISO 10993-1:2009/AC:2010) has been prepared by Technical Committee ISO/TC 194
"Biological evaluation of medical devices" in collaboration with Technical Committee CEN/TC 206 Biological
evaluation of medical devices the secretariat of which is held by NEN.
Endorsement notice
The text of ISO 10993-1:2009/Cor 1:2010 has been approved by CEN as a EN ISO 10993-1:2009/AC:2010
without any modification.

INTERNATIONAL STANDARD ISO 10993-1:2009

TECHNICAL CORRIGENDUM 1
Published 2010-06-15
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

ORGANISATION INTERNATIONALE DE NORMALISATION

Biological evaluation of medical devices

Part 1:
Evaluation and testing within a risk management process
TECHNICAL CORRIGENDUM 1
valuation biologique des dispositifs mdicaux
Partie 1: valuation et essais au sein d'un processus de gestion du risque
RECTIFICATIF TECHNIQUE 1

Technical Corrigendum 1 to ISO 10993-1:2009 was prepared by Technical Committee ISO/TC 194, Biological
evaluation of medical devices.

Page 5, Figure 1
On the top left-hand side of the flowchart, and to the right of the rhombus indicating Is there either direct or
indirect contact?, replace 1.0 with Clause 1.
On the lower left-hand side of the flowchart, and to the top right of the rectangle indicating Perform further
evaluation of device ... and type and duration of contact, replace 7.0 with Clause 7.
On the lower right-hand side of the flowchart, replace the text in the bottom right rectangle with Perform
toxicological risk assessment (Annex B).

ICS 11.100.20
ISO 2010 All rights reserved
Published in Switzerland

Ref. No. ISO 10993-1:2009/Cor.1:2010(E)